510(k) Report

Devices descending from K012000

5 later devices reach 1.5MM Bone Fixation Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K0319812.4 Smartnail, Models 532416, 532425, 532435, 532445Linvatec Biomaterials, Ltd.20033—
+1K013546Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214Bionx Implants, Inc.20014—
+2K041288Modification to SmartpinLinvatec Biomaterials, Inc.20042—
+3K073311Osteotrans-OT PinTakiron Co., Ltd.20080—
+3K071616Arc Surgical Biotrak Pin SystemArc Surgical, LLC20070—